E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lupus Nephritis (LN)
Immunoglobulin A Nephropathy (IgAN) |
|
E.1.1.1 | Medical condition in easily understood language |
Lupus Nephritis (LN)
Immunoglobulin A Nephropathy (IgAN) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10025140 |
E.1.2 | Term | Lupus nephritis |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021263 |
E.1.2 | Term | IgA nephropathy |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Efficacy of ravulizumab compared with placebo in adult participants with LN and IgAN |
|
E.2.2 | Secondary objectives of the trial |
Safety and tolerability of ravulizumab and additional efficacy measures |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Common to both disease cohorts:
- 18 - 75 years of age
- Proteinuria ≥ 1 (g/d or g/g)
- Vaccinated against meningococcal infection
- Vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae
For LN cohort:
- Diagnosis of active focal or diffuse proliferative LN Class III or IV
- Clinical active LN, requiring/receiving immunosuppression induction treatment
For IgAN cohort:
- Diagnosis of primary IgAN
- Compliance with stable and optimal dose of RAS inhibitor treatment for ≥ 3 months
For a full list of inclusion criteria please refer to the clinical study protocol, section 5.1. |
|
E.4 | Principal exclusion criteria |
Common to both disease cohorts:
- Estimated GFR < 30 mL/min/1.73 m2
- Previously received a complement inhibitor (eg, eculizumab) at any time
- Concomitant significant renal disease other than LN or IgAN
- History of other solid organ or bone marrow transplant
- Uncontrolled hypertension
For IgAN cohort:
- Diagnosis of rapid progressive glomerulonephritis
- Prednisone or prednisone equivalent > 20 mg for > 14 consecutive days or any other immunosuppression within 6 months
For a full list of exclusion criteria please refer to the clinical study protocol, section 5.2. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage change in proteinuria |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Common to both disease cohorts:
- Percentage change in proteinuria
- Change from baseline in eGFR
For LN:
- Percentage of participants meeting the criteria for Complete Renal Response
- Percentage of participants meeting the criteria for Partial Renal Response
- Time to UPCR (Urine Protein to Creatinine Ratio) < 0.5 g/g
- Percentage of participants achieving corticosteroid taper to 7.5 mg/day
- Percentage of participants with Renal Flare
- Percentage of participants with Extrarenal SLE (Systemic Lupus Erythematosus) Flare
For IgAN:
- Percentage of participants meeting the criteria for Partial Remission |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout, Week 26 and/or Week 50 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Korea, Republic of |
Singapore |
Taiwan |
United States |
Belgium |
France |
Germany |
Italy |
Netherlands |
Poland |
Spain |
Sweden |
United Kingdom |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |